Policy Tag: Prescription

Adopted by the 61st WMA General Assembly, Vancouver, Canada, October 2010 and
reaffirmed with minor revisions by the 215th Council session (on line), Cordoba, Spain, October 2020

PREAMBLE

From the beginning of their studies and throughout their professional careers, physicians acquire the knowledge, training and competence required to treat their patients with the utmost skill and care.

Physicians determine the most accurate diagnosis and the most effective treatment to cure illness, or alleviate its effects, taking into consideration the overall condition of the patient.

Pharmaceutical products are often an essential part of the treatment approach. In order to make the right decisions in accordance with the ethical and professional principles of medical practice, the physician must have a thorough knowledge and understanding of the principles of pharmacology and possible interactions among different drugs and their effects on the health of the patient.

The prescribing of medication is a significant clinical intervention, which should be preceded by multiple, integrated processes to assess the patient and determine the correct clinical diagnosis. These processes include:

  • Taking a history of the current condition and past medical history;
  • The ability to make differential diagnosis;
  • Understanding any multiple chronic and complex illnesses involved;
  • Taking a history of the medications currently being administered successfully or previously withdrawn and also being aware of possible interactions.

Inappropriate drug prescription without proper knowledge and accurate diagnosis may cause serious adverse effects on the patient’s health. In view of the possible serious consequences that may result from an inappropriate therapeutic decision, the WMA affirms the following principles on high quality treatment and ensuring patient safety.

The WMA reiterates its support to its statements on the Relationship between Physicians and Pharmacists in Medicinal Therapy and on Biosimilar Medicinal Products.

PRINCIPLES

  1. Prescription of drugs should be based on a correct diagnosis of the patient’s condition and should be performed by those who have successfully completed a curriculum on disease mechanisms, diagnostic methods and medical treatment of the condition in question.
  2. Prescriptions issued by physicians are vital for ensuring patient safety, which in turn is critical for maintaining the relationship of trust between patients and their physicians.
  3. Although nurses and other healthcare workers cooperate in the overall treatment of patients, the physician is the best qualified individuals to prescribe independently. In some countries, laws may allow for other professionals to prescribe drugs under specific circumstances, generally with extra training and education and most often under medical supervision. In all cases, the responsibility for the patient’s treatment must remain with the physician. Each country’s medical system should ensure the protection of public interest and safety in the diagnosis and treatment of patients. If a system fails to comply with this basic framework due to social, economical or other compelling reasons, it should make every effort to improve the situation and to protect the safety of the patients.

Adopted by the 53rd WMA General Assembly, Washington, DC, USA, October 2002
Reaffirmed by the 191st WMA Council Session, Prague, Czech Republic, April 2012
and reaffirmed with minor revisions by the 221st WMA Council Session, Berlin, Germany, October 2022

 

PREAMBLE

This statement aims to provide guidance on responsible self-medication.

Medicinal products can generally be divided into two separate categories: prescription and non-prescription medicines. This classification may differ from country to country. The national authorities must assure that medicines, categorized as non-prescription medicines, are sufficiently safe not to be harmful to health.

Prescription medicines are those which are only available to individuals on prescription from a physician or other authorized health professionals following a consultation. Prescription medicines are not safe for use except under the supervision of the health professional because of toxicity, other potential or harmful effects (e.g. addictiveness), the method of use, or the collateral measures necessary for use.

Responsible self-medication, as referred in this document, is the use of a registered or monographed medicine legally available without a physician’s prescription, either on an individual’s own initiative or following advice of a healthcare professional. The use of prescription medicines without a prior medical prescription is not part of responsible self-medication.

 

RECOMMENDATIONS

  1. The safety, efficacy and quality of non-prescription medicines must be proved according to the same principles as prescription medicines.
  2. Given the risk of using unprescribed medicine and/or irresponsible self-medication, the WMA recommends the following:

For individuals

  1. Patients should inform their physicians or other healthcare professionals concerned whenever they self-medicate in conjunction with other prescribed medication. A course of treatment may combine self-medication and prescription medication, either concurrently or sequentially. The patient must be informed about possible interactions between prescription medicines and non-prescription medicines. For this reason, the patient should be encouraged to inform the health professional about his / her self-medication.
  2. In self-medication, the individual bears primary responsibility for the use of self-medication products. Special caution must be exercised when vulnerable groups such as children, elderly people or pregnant women use self-medication.
  3. If individuals choose to use self-medication, they should be able:
  • to recognize the symptoms they are treating;
  • to determine that their condition is suitable for self-medication;
  • to choose an appropriate self-medication product;
  • to follow the directions for use of the product as provided in the product labelling.

For health professionals

  1. Physicians and other health professionals concerned must educate patients about the potential risks involved in self-medication and its appropriate use, and instructions them to seek further medical advice if they are unsure. This is particularly important where self-medication is inappropriate for certain conditions the patient may suffer from.
  2. Information to the patients should include a warning against pseudoscience and pseudo therapies, which have no scientific basis, as stated in the WMA Declaration on Pseudoscience and Pseudotherapies in the field of health.
  3. Health professionals should encourage patients to carefully read a product’s label and leaflet (if provided), to seek further advice if necessary, and to recognize circumstances in which self-medication is not, or is no longer, appropriate.
  4. Pharmacists have a professional responsibility to recommend that patients seek medical attention, especially when in case of symptoms that warrant them to do so or if patients ask for medication that can be only be given to them after prescription.
  5. Health professionals should seek to identify potentially relevant self-medication during medical consultations, drug dispensing at the pharmacy and during home-based nursing interventions.

For other stakeholders

  1. Governments should recognize and enforce the distinction between prescription and non-prescription medicines and ensure that the users of self-medication are well informed and protected from possible harm or negative long-term effects.
  2. Manufacturers are obliged to follow the various codes or regulations already in place to ensure that information provided to consumers is appropriate in style and content. This refers in particular to the labelling, advertising and all notices concerning non-prescription medicines.
  3. Advertising and marketing of non-prescription medicines should be responsible, provide clear and accurate information and exhibit a fair balance between benefit and risk information. Promotion and marketing should not encourage irresponsible self-medication, purchase of medicines that are inappropriate, or purchases of larger quantities of medicines than are necessary.
  4. Pharmacovigilance for self-medication should be organized and reinforced by both governments and the industry to control the risks associated with self-medication.

For all

  1. All parties involved in self-medication should treat medicines (prescription and non-prescription) as special products. Standard precautions should be followed in terms of safe storage and usage, in accordance with professional advice.
  2. All parties involved in self-medication should be aware of the benefits and risks of any self-medication product. The benefit-risk balance should be communicated in a fair, rational manner without overemphasizing either the risks or the benefits.